Why Food Safety Plans must consider chemical hazards

By: Tom Neltner, J.D.Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant, Environmental Defense Fund

Since September 17, 2016, most facilities storing, processing, or manufacturing food are required to identify and, if necessary, control potential hazards in food under a Preventive Controls Rule promulgated by the Food and Drug Administration (FDA) pursuant to the FDA Food Safety Modernization Act of 2011 (FSMA). Some foods have had similar requirements in place for years. For example, fruit and vegetable juice processors have been required to have a Hazard Analysis and Critical Control Point (HACCP) Plan since the early 2000s.

Record numbers of consumers rate chemicals as their top food safety concern A Food Safety Plan required by FDA is an effective means to respond to this concern and proactively manage risks posed by chemicals instead of reacting to often preventable incidents.

The driving force behind the law and the rules has been reducing the hazard of pathogenic contamination in food. However, the Preventive Controls Rule defines a hazard broadly to include any chemical, whether a contaminant or an additive, that “has the potential to cause illness or injury.”

In this blog, we will explore how the requirements of the Preventive Controls Rule apply to chemical hazards using lead as an example. We chose lead because it is known to cause injury and clearly meets the definition of a hazard. It is well-established that there is no safe level of lead in the blood of children leading to lower IQ and academic achievement, and increases in attention related behaviors. We also know it is all too common in food that toddlers eat. And scientific evidence indicates that much of the lead in food gets into children’s blood.

Four potential sources of lead in the food supply chain

Lead can get into food in different ways including:

  • Absorption from contaminated soil into the roots, leaves, and, possibly, fruit. Soil may be contaminated from past use of lead arsenate pesticides or air deposition from burning leaded gasoline.
  • Contact with contaminated soil during production or harvesting. For example, soil may get into a head of lettuce or on an apple that falls to the ground.
  • Leaching from food handling equipment such as that made from brass or plastic that had lead intentionally added. Until 2014, brass used in drinking water applications could contain up to 8% lead and still be called lead-free. If such brass were used in pumps and valves in food production, leaching of lead into food may occur. Similarly, lead has also been used in PVC plastic as a stabilizer, although it has been phased out in U.S. and Europe. It is important to note that lead is not approved by FDA to be intentionally added to anything that contacts food. If any leaches into food from these sources, the lead would be considered an unapproved food additive. That would render the food adulterated and, therefore, illegal to sell. Note that a supplier’s claim that a material is “food grade” is no guarantee that its use is legal.
  • Contamination of food or food contact materials during processing such as lead from deteriorated paint in the building.

Elements of a Food Safety Plan

Under the Preventive Controls Rule, most facilities storing, processing or manufacturing food must have a written Food Safety Plan that consists of seven items:

  1. A hazard analysis to identify and evaluate known or reasonably foreseeable hazards;
  2. Preventive controls to ensure hazards are significantly minimized or prevented and food will not be adulterated;
  3. Risk-based supply chain program to protect raw materials and ingredients from hazards;
  4. Plan for recalls should they be necessary;
  5. Procedures to monitor preventive controls to assure they are consistently performed;
  6. Corrective action procedures if preventive controls are not properly implemented; and
  7. Verification procedures to validate that preventive controls are adequate and effective, other procedures are being followed, and plan is reevaluated at least once every three years.

The path forward

The FSMA food safety planning requirements put in place a systematic approach for food manufacturers to prevent food safety problems rather than react when they arise. This includes problems that can result from chemical hazards as well as pathogens. The goal is to ensure that consumers are not exposed to adulterated food, whether because it contains “any poisonous or deleterious substance which may render it injurious to health” or it contains an unapproved food or color additive.

A robust food safety plan for lead and other chemicals such as perchlorate would go a long way to protect children and pregnant women from unnecessary exposures to chemicals known to impair brain development, and the businesses from unnecessary risk.

What a Food Safety Plan would say for lead

To comply with the regulations and mitigate risk, the food manufacturer/processor’s written food safety plan is required to identify lead as a hazard if it is reasonably foreseeable that lead could get into food either as a contaminant or from its intentional addition to materials such as brass or plastic used in food handling equipment.

If the plan identifies lead as a hazard, the company must evaluate the risk by assessing (1) the severity of the illness or injury if the hazard were to occur, and (2) the probability that the hazard will occur in the absence of preventive controls. The plan must also develop and implement preventive controls to assure lead levels are significantly minimized or prevented and the food is not adulterated. The controls would likely include:

Next, the company must identify how the preventive controls would be monitored to spot implementation problems, explain how a recall would be conducted if lead were found to exceed the maximum amount identified in the plan or is present as an unapproved food additive, and describe what corrective action would be taken to prevent future recalls.

Finally, the food manufacturer/processor must reanalyze its Food Safety Plan at least every three years or when:

  1. There is a significant change in the activities conducted at the facility that creates a reasonable potential for a new hazard or creates a significant increase in a previously identified hazard;
  2. The food manufacturer becomes aware of new information about potential hazards associated with the food;
  3. An unanticipated food safety problem occurs; or
  4. The food manufacturer finds the preventive control, combination of preventive controls, or the food safety plan as a whole is ineffective.

The Food Safety Plans are not made publicly available, but they must be made available to FDA on request or during an inspection. Potential downstream buyers and retailers most likely can obtain a copy through their own supply chain management programs.

Consumer Concern About Chemicals in Food Continues to Grow

Behind the Label_FFor the second year in a row, more than a third of consumers participating in the annual food industry survey rated chemicals in food as their most important food safety issue. Every year for the past decade, the International Food Information Council (IFIC) has surveyed more than 1,000 Americans aged 18-80, to gain insight into their attitudes towards food and diet. Although the way they have polled on these topics has changed over the years, the research shows a clear and steady rise in the number of Americans concerned about chemicals in their food.

In 2016, IFIC broke down the ‘chemicals in food’ option from 2015 into more specific concerns: chemicals in food (arsenic, mercury, BPA); carcinogens or cancer-causing chemicals in food; and food additives and ingredients (caffeine, MSG, flavors, colors, preservatives, etc.).

food-survey-graphics_block_2_croppedFor 38 percent of the respondents, these three specific sub-categories of chemicals in food combined were the most important food safety issue, a two-point jump since last year. And these concerns are being felt in the market: 40% of consumers who stated that chemicals were of great concern to them reported changing their eating habits.

Growing concern driving food supply chain changes

Consumers’ growing concern about chemicals reflects an increased awareness about the harmful effects they may have on human health and, importantly, a shift in how consumers are defining the issue of “safety” in food. As we reported a few months ago, a report from Deloitte, the Food Marketing Institute and the Grocery Manufacturers Association found that consumers are increasingly concerned about the short-term health effects of chemicals in food (e.g., no toxins) as well as the long-term effects (e.g. no carcinogens).

To their credit, the food industry is beginning to respond to these concerns. Read more

Can You Taste That Smell? Maybe You Don’t Want To.

Recently, SC Johnson took the next step in product transparency, becoming the first major player in the consumer goods industry to disclose 100 percent of fragrance ingredients for a product line – in this case, its Glade® Fresh Citrus Blossoms collection. Consumers can now see what chemicals make up these home fragrances by reading product packaging or visiting SCJ’s WhatsInsideSCJohnson.com ingredient website. Over time, the company will expand the disclosure to the rest of its air fresheners and other products.

WhatsInSCJohnsonThis is meaningful. Industry-wide, major consumer goods companies list fragrances in aggregate on an ingredient list, whereas in actuality, those fragrances are composed of many individual chemicals. Consumers deserve greater transparency.

As SCJ Chairman and CEO Fisk Johnson noted, “… key to [making thoughtful ingredient choices] is continually challenging the status quo. By sharing the full ingredient list for this fragrance — all the way down to the component level — we’re going beyond the norm of even so-called ‘natural’ products.”

EDF has applauded SCJ’s efforts on fragrance disclosure in the past, and we encourage them to continue increasing transparency throughout its product line. Read more

Why EDF May Decline a Seat at the Consensus Standard Table

Have you ever looked at the tag on your power supply and wondered what all those symbols meant? Many of them represent a voluntary consensus standard designed to protect the safety and health of the user.

Since we believe these types of standards can serve a valuable purpose, we wanted to explain why and how we make the decision to participate – and why we and other NGOs recently withdrew from one such effort by NSF International, funded by the Grocery Manufacturers Association (GMA).

LabelsConsensus Standards

Put simply, a voluntary consensus standard means a relevant and balanced group of stakeholders got together and reached agreement on how to do something voluntarily and consistently that serves national needs.

For example, NSF/ANSI Standard 61: Drinking Water System Components sets health effects criteria for many water system components such as pipes and faucets. Such standards, overseen by the American National Standards Institute (ANSI), can create assurance that might otherwise require regulation.

As you’ll read below, the ANSI due process guidance for consensus standards require balance in the range of viewpoints considered. EDF increasingly finds itself invited to represent the public interest point of view. Read more

Consumers’ Changing Views on Food Safety, and the Opportunity for Action

Behind the Label_FConsumers demand safe food, and they prioritize purchasing from brands that they trust to be safe. The food industry knows this and wisely makes safety a top priority. But consumers’ definition of safety is changing, and the food industry needs to evolve its practices to keep pace with consumer demand.

Customers have traditionally defined safety as “free of harmful elements.” Last year, more than thirty-six percent of consumers said chemicals in their food was their top food safety concern. A new report from Deloitte, the Food Marketing Institute (FMI) and Grocery Manufacturers Association (GMA) found that definition of safety has expanded — that consumers consider safety both a short-term (e.g., toxin free) as well as a long-term (e.g., no carcinogens) concern and, as a result, it aligns with their health and wellness concerns.

Deloitte-FMI-GMA-report-coverThis expanded definition of safety includes attributes such as clear and accurate labeling; clear information on ingredients, both label and sourcing; fewer ingredients, processing and no artificial additives; and better nutritional content.

The message is clear: Retailers and food manufacturers need to adapt, or they risk losing market share to competitors who meet evolving customer demands with safer ingredients and improved transparency.

Read more

Securing Safer Chemicals in Food

Behind the Label - the blueprint for safer products in the marketplaceIt seems that almost every week, another major food company announces plans to remove artificial colors and flavors from their products. In the past six months, major food companies such as Nestle, General Mills, Kellogg's, Hershey’s and Campbell’s committed to reformulating many of their iconic brands to be free of artificial colors and  flavors. National restaurant chains such as Pizza Hut, Taco Bell, Subway and Noodles & Company also made similar commitments. Tens of billions of dollars of products are being reformulated.

What’s driving all this change?

It turns out more and more Americans are concerned about what goes into their food, especially when it comes to the thousands of chemical additives—substances used to color, preserve, flavor, or emulsify food or to process or package food, like phthalates.

According to a May 2015 industry survey, 36% of consumers polled said chemicals in food was their most important safety issue for them and their families today — more than pesticides, animal antibiotics, undeclared allergens and pathogens. This is up from 9% in 2011. What’s more, 23% said they changed food purchases as a result of information they learned about chemicals, pesticide residues, and animal antibiotics.

woman reading labelAnother survey by CivicScience published the same month reported similar numbers with health concerns about preservatives and chemicals rating higher  than added sugar, saturated fats, and sodium. These weren’t urban foodies following the latest trends on social media: those most concerned were generally from rural areas, more likely to be influenced by TV news, and less likely to eat out or use social media. With numbers like these, no wonder the food industry is scrambling to respond.

There is good reason to be concerned about potentially unsafe chemicals in the food supply, and importantly, the problem extends well beyond whether an ingredient might be artificial. So, while these recent efforts to remove artificial ingredients respond to mounting consumer concerns, they won’t sate the consumer’s appetite for healthier and safer foods.

EDF is launching a new initiative to move potentially unsafe chemicals from the food supply by harnessing the transformative power of supply chains. EDF’s Behind the Label: A Blueprint for Safer Food Additives provides a roadmap for corporate leadership that moves companies from a reactionary response to artificial ingredients to a proactive approach to ensure safer, simpler food.  We’re excited to have Tom Neltner leading this new effort on safer chemicals in food.  Tom spent years investigating the safety of chemical food additives at the Pew Charitable Trusts and the Natural Resources Defense Council.

In the coming weeks and months, we’ll be outlining the problem of potentially unsafe chemicals in food, the current state of the market response to rising concerns, and our vision for corporate leadership for safer chemicals in food.